After obtaining the CE certification, which proves that the developed medical device fulfills the minimum legal and technical requirements in safety matters in the Member States of the European Union, the innovative and pioneering technique for the Pectus Excavatum treatment continues to obtain quality certifications.
The Spanish Agency of Medicines and Medical Devices (AEMPS) and the French National Agency for Medicines and Health Products Safety (ANSM) have given Ventura Medical Technologies authorisation to commercialize Pectus Up Surgery Kit in all Spain and in France.
The AEMPS is responsible for giving the authorisation to commercialise industrially fabricated drugs for human use, and for inspection and adaptation of the already commercialised ones. Accordingly, it is the maximum responsible for controlling drugs and medical devices of state competency, and preserving the quality guarantee, safety, efficacy, information and accessibility to drugs and medical devices in Spain.
The state organism has certified that the Pectus Up Surgery Kit is a medical device of quality, and that it perfectly fits the Spanish regulation regarding medical devices. Therefore, the AEMPS authorises Ventura Medical Technologies to distribute the most innovative product for the treatment of Pectus Excavatum.
However the Spanish state is not the only European state which recognises Pectus Up Surgery Kit benefits. The ANSM has opened the borders to an until now nonexistent product and technique, guarantors of less pain, absence of important complications and a faster recovery.
The ASNM is a French public organization with the purpose of assessing the sanitary risks that drugs and other medical devices for the French population may present. Its certification guarantees the quality of Pectus Up Surgery Kit in accordance with the French standards in matters of quality, safety and efficacy